الحالات

A Saudi pharmaceutical company specializing in high-potency API manufacturing needed to upgrade their powder handling process to meet OEB-5 containment standards. Their existing equipment was unable to achieve the required containment levels, posing safety risks to operators and failing to comply with strict regulatory inspections. Minyue provided a complete solution including vacuum conveyors, a sterile powder mixer with CIP/SIP functionality, and a cone mill with contained transfer systems. All equipment was designed to meet cGMP and OEB-5 standards, ensuring operator safety and product integrity. The project was delivered within 45 days, including installation, validation, and staff training. The pharmaceutical company passed their subsequent regulatory audit with zero non-conformities and has since recommended Minyue to three other manufacturers in the region.